Relapsed and Refractory Acute Myeloid Leukemia (RR-AML)Phase 2NCT07874737
Mitoxantrone Hydrochloride Liposome Combined With Cladribine And Sotorasib For Relapsed Refractory Acute Myeloid Leukemia
A Phase 2 study testing Mitoxantrone Hydrochloride Liposome+cladribine+sotoraclib in people with Relapsed and Refractory Acute Myeloid Leukemia (RR-AML), run by The Affiliated People's Hospital of Ningbo University.
Trial summary
This is a single-arm, single-center clinical study to assess the efficacy and safety of Mitoxantrone Hydrochloride Liposome combined with cladribine and sotoraclib in patients with relapsed/refractory acute myeloid leukemia (R/R-AML). Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Relapsed and Refractory Acute Myeloid Leukemia (RR-AML)
- What is being tested?
- Mitoxantrone Hydrochloride Liposome+cladribine+sotoraclib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to May 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥16 and <65 years old.
- Confirmed diagnosis of acute myeloid leukemia (AML) according to WHO classification.
- Relapsed or refractory AML after at least one prior line of anti-leukemia therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Adequate organ function: total bilirubin ≤1.5 × upper limit of normal (ULN); alanine transaminase (ALT) and aspartate transaminase (AST) ≤2.5 × ULN; estimated creatinine clearance ≥50 mL/min.
- Women of child-bearing potential must have negative pregnancy test; all patients must agree to use effective contraception during study treatment and for 6 months after last dose.
- Voluntarily sign written informed consent.
Who cannot join
- Acute promyelocytic leukemia (APL).
- Prior allogeneic hematopoietic stem cell transplant within 100 days before enrollment.
- Active uncontrolled severe infection.
- Clinically significant cardiovascular disease including uncontrolled arrhythmia, myocardial infarction within 6 months.
- Known central nervous system leukemia.
- Pregnant or breastfeeding women.
- Any severe medical or psychiatric condition that would interfere with study participation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Clinical Study Of Mitoxantrone Hydrochloride Liposome Plus Cladribine Combined With Sotorasib In Patients With Relapsed And Refractory Acute Myeloid Leukemia
This is a single-arm, single-center clinical study to assess the efficacy and safety of Mitoxantrone Hydrochloride Liposome combined with cladribine and sotoraclib in patients with relapsed/refractory acute myeloid leukemia (R/R-AML). Eligible adult participants will receive the following regimen: Mitoxantrone Hydrochloride Liposome 20 mg/m²; cladribine 5 mg/m² on day 1-5; sotoraclib 20 mg on day1, 40 mg on day2, 80 mg on day3, 160 mg on day4-day9. Clinical efficacy endpoints include overall response rate. Safety will be assessed via adverse event monitoring and laboratory examinations. All subjects will be followed up for survival and relapse status.
- Being tested
- Mitoxantrone Hydrochloride Liposome+cladribine+sotoraclib
- Medical subject headings
- Recurrence, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitoxantrone Hydrochloride Liposome+cladribine+sotoraclibDrug
Mitoxantrone Hydrochloride Liposome 20 mg/m² intravenous infusion on Day 1; cladribine 5 mg/m² intravenous infusion on Day 1-Day 5; sotoraclib 20 mg Day1, 40 mg Day2, 80 mg Day3, 160 mg Day4-Day9 intravenous infusion, administered as one treatment cycle.
| Study group | Role | What they receive |
|---|---|---|
| Mitoxantrone Hydrochloride Liposome-cladribine-sotoraclib Combination Therapy Arm | Experimental | Not described Receives: Drug: Mitoxantrone Hydrochloride Liposome+cladribine+sotoraclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
Measured: At the end of Cycle 1 (each cycle is 28 days)
Secondary outcomes (2)
Complete Remission (CR) Rate
Measured: At the end of Cycle 1 (each cycle is 28 days), with follow-up up to 6 months.
Safety: Incidence of Adverse Events
Measured: From first dose up to 30-days after last study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed and Refractory Acute Myeloid Leukemia (RR-AML)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated People's Hospital of Ningbo University
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07874737
- Sponsor's protocol ID
- 2026-R/R-AML
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study Of Mitoxantrone Hydrochloride Liposome Plus Cladribine Combined With Sotorasib In Patients With Relapsed And Refractory Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT07874737
- Acronym / sponsor ID
- 2026-R/R-AML
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The Affiliated People's Hospital of Ningbo UniversityOther government
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 15 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-arm, single-center clinical study to assess the efficacy and safety of Mitoxantrone Hydrochloride Liposome combined with cladribine and sotoraclib in patients with relapsed/refractory acute myeloid leukemia (R/R-AML). Eligible adult participants will receive the following regimen: Mitoxantrone Hydrochloride Liposome 20 mg/m²; cladribine 5 mg/m² on day 1-5; sotoraclib 20 mg on day1, 40 mg on day2, 80 mg on day3, 160 mg on day4-day9. Clinical efficacy endpoints include overall response rate. Safety will be assessed via adverse event monitoring and laboratory examinations. All subjects will be followed up for survival and relapse status.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mitoxantrone Hydrochloride Liposome-cladribine-sotoraclib Combination Therapy Arm | Experimental | Drug: Mitoxantrone Hydrochloride Liposome+cladribine+sotoraclib |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥16 and <65 years old.
Key exclusion criteria (7 listed)
- Acute promyelocytic leukemia (APL).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mitoxantrone Hydrochloride Liposome+cladribine+sotoraclibMitoxantrone Hydrochloride Liposome 20 mg/m² intravenous infusion on Day 1; cladribine 5 mg/m² intravenous infusion on Day 1-Day 5; sotoraclib 20 mg Day1, 40 mg Day2, 80 mg Day3, 160 mg Day4-Day9 intravenous infusion, administered as one treatment cycle. | Drug | Mitoxantrone Hydrochloride Liposome-cladribine-sotoraclib Combination Therapy Arm |
Primary outcome
Overall Response Rate (ORR)
Time frame: At the end of Cycle 1 (each cycle is 28 days)
2 secondary outcomes
Complete Remission (CR) Rate
Time frame: At the end of Cycle 1 (each cycle is 28 days), with follow-up up to 6 months.
Safety: Incidence of Adverse Events
Time frame: From first dose up to 30-days after last study drug administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mitoxantrone Hydrochloride Liposome+cladribine+sotoraclib in people with Relapsed and Refractory Acute Myeloid Leukemia (RR-AML), run by The Affiliated People's Hospital of Ningbo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ying Lu (86+13486090834, rmluying@nbu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) (time frame: At the end of Cycle 1 (each cycle is 28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.